Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 20 of 393 for:    PYY

Effect of a Physical Activity Program on the Hormonal Regulation of Food Intake (APHRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01824680
Recruitment Status : Suspended
First Posted : April 5, 2013
Last Update Posted : April 5, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

The primary purpose of this protocol is to assess the hormonal regulation of satiety by an intense exercise before and after a 3 month physical activity program. Hormones assessed are: leptin, grhélin, Cholecystokinin, Glucagon-Like-Peptid-1 (GLP-1), PYY.

It is well known that in overweight adults and children also, an intense physical exercise diminish the food intake relatively to the total energy expenditure and this effect is persistent after a 6 weeks physical activity program.

Our hypothesis are: a diminution of food intake after the intense physical exercise and a persistent diminution of food intake after the 3 month physical activity program, an augmentation of levels of GLP-1 and PYY during the intense exercise before and after the physical activity program, a diminution of the level of GLP-1 and leptin before and after the physical activity program


Condition or disease Intervention/treatment Phase
Obesity Behavioral: Physical activity Not Applicable

Detailed Description:

There is two sequences, one before and one after the physical activity program. Each sequence contains one "rest" session and one "exercise" session.

Each session contains : blood sample at regular interval (Leptin, Ghrélin, CCK, PYY, GLP-1), a sleeping assessment (Pittsburg scale), an assessment of hunger sensations at regular interval, an assessment of food intake in a "ad libitum" lunch and in the diner indirectly by the SU.VI.MAX. tool.

During the " rest " session :

Blood samples, assessment of hunger sensation, assessment of food intake are realized during the morning. Physical condition (VO2 max, DEXA, and muscular test), insulin-sensibility, lipid profile, are also assessed.

During the "exercise" session: it is identical to the first session but an intense exercise of 40 minutes is realized at 70% of the patient's VO2 max. The peripherical blood output is measured by a non-invasive method: the Near-Infra-Red-Spectroscopy, during the exercise.

The 3-months-physical activity program : there is 4 sessions of 30 minutes and 2 sessions of 1 hour per week. Most of exercises sessions are realized at home but one 1-hour session per week is controled with a sports educator.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of a 3 Months Physical Activity Program on the Hormonal Regulation of Food Intake by Intense Physical Activity in Overweight Adolescents
Study Start Date : October 2012
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: obesity Behavioral: Physical activity
There is two sequences, one before and one after the physical activity program. Each sequence contains one "rest" session and one "exercise" session




Primary Outcome Measures :
  1. Comparison before and after the physical activity program of the effect of intense exercise on kinetic of secretion of regulation hormones: Leptin, Grhélin, CCK, PYY3-36, GLP-1 [ Time Frame: after 3 months of physical activity ]

Secondary Outcome Measures :
  1. Comparison, before and after the physical activity program, of Hunger sensation by Visual Analogic Scales [ Time Frame: after 3 months of physical activity ]
  2. Comparison, before and after the physical activity program of food intake [ Time Frame: after 3 months of physical activity ]
  3. Comparison, before and after the physical activity program of insulinosensibility [ Time Frame: after 3 months of physical activity ]
  4. Comparison, before and after the physical activity program of peripheral blood output [ Time Frame: after 3 months of physical activity ]
  5. Comparison, before and after the physical activity program of sleep quality [ Time Frame: agter 3 months of physical activity ]
  6. Comparison, before and after the physical activity program of physical condition [ Time Frame: after 3 months of physical activity ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Overweight adolescents (over the 90 th percentile of the international cut-off point)

  • With a computer and an internet connection
  • Sedentary (according to the IPAQ-A questionnaire)
  • Without eating disorders (according to the DEBQ questionnaire)

Exclusion Criteria:

  • Medical or surgical antecedents that are incompatible with the study: cardiovascular, endocrine or digestive disease.
  • Drugs that could interfere with the results of the study
  • Surgical intervention in the 3 months
  • Regular consumption of tobacco or Alcohol
  • patients on a diet with caloric restriction
  • Refusal to sign the consent form
  • Regular practice of sport and intensive

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824680


Locations
Layout table for location information
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Layout table for investigator information
Principal Investigator: Etienne MERLIN University Hospital, Clermont-Ferrand

Layout table for additonal information
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01824680     History of Changes
Other Study ID Numbers: CHU-0149
First Posted: April 5, 2013    Key Record Dates
Last Update Posted: April 5, 2013
Last Verified: April 2013

Keywords provided by University Hospital, Clermont-Ferrand:
Obesity
Appetite regulation
Hormones
Adolescents
Exercise